MedTrace Logo

Collection of Electrophysiological Data During Colon Resection

NCT04854473 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2021-05-06

No results posted yet for this study

Summary

The study is conducted to record continuous electrophysiological signals from intact and ischemic bowel tissue during colonic resection surgery, in order to train the Exero Medical Leak Detection System classification algorithm on detection of ischemic conditions.

Conditions

  • Open/ Laparoscopic/ Robotic Resection of the Colon

Interventions

DEVICE

Exero Medical Leak Detection System

the Exero Leak Detection System components used in this study are: * Smart drain - a surgical drain with added sensing electrodes * Transceiver /Recording Unit (TRU) - a wearable placed outside the body on intact skin and is connected to the implanted electrodes. The unit also acts as a wireless connection to the Monitoring Subsystem. * Monitoring Subsystem - a tablet or a computer connected wirelessly to the transceiver providing logging, applying analysis algorithms on the logged signals and providing indication/alerts to the medical staff derived from the signals recorded by the electrodes.

Sponsors & Collaborators

  • Exero Medical Ltd.

    lead INDUSTRY

Principal Investigators

  • Nir Wasserberg, MD · Rabin Medical Center

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-04
Primary Completion
2020-09-17
Completion
2020-09-17

Countries

  • Israel

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04854473 on ClinicalTrials.gov